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| ID | Type | Description | Link |
|---|---|---|---|
| Grant No. 114-HCH069 | Other Grant/Funding Number | National Taiwan University Hospital Hsin-Chu Branch |
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Preoperative anxiety begins from the decision-making of surgery to entering the operating room and may intensify as the surgery date approaches. Anxiety not only causes physiological effects but also psychological impacts, leading to negative outcomes for postoperative recovery. Ambulatory surgeries often employ local anesthesia, where patients remain conscious during the procedure, potentially causing specific anxieties and fears. The use of a stress ball is a non-pharmacological method that effectively distracts individuals consciously focusing on stimuli. This study is expected to be a randomized controlled trial, using convenience sampling to select patients receiving local anesthesia. They will be divided into two groups through computer-generated random number sequences: the stress ball group and the control group. The research aims to alleviate anxiety and pain levels in outpatient surgery patients receiving local anesthesia, with the goal of improving patients' postoperative mental health and quality of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | usal nursing care | |
| intervation group | Experimental | stress ball |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stress ball | Device | Stress ball: It is a ball with moderate hardness and softness, about 6 cm, which can be held and pressed by hand. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | It is a physiological monitoring indicator. When the human body receives internal and external environmental stimuli, the autonomic nervous system regulates the heart rhythm to perform a series of responses to the stimulus source (Huang et al., 2008). Heart Rate Variability (HRV) is an objective physiological indicator that can be used An assessment tool for anxiety status during surgery (Correa et al., 2021; Tang et al., 2006). | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory, S-TAI | It is based on the individual's feelings in a specific situation. | 5 - 10 minutes |
| Visual Analogue Scale | Measure the patient's pain level using VAS 0 to 10 |
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Inclusion criteria were: (1) age ≥ 18 years and able to communicate in Mandarin or Taiwanese Hokkien; and (2) scheduled to undergo outpatient hand surgery under local anesthesia.
Exclusion criteria were: (1) use of anxiolytics or sedatives within one week prior to surgery; (2) concurrent bilateral hand surgery during the same operative session; and (3) known cardiac arrhythmia or use of a cardiac pacemaker.
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| Name | Affiliation | Role |
|---|---|---|
| Hsueh-Ling Chang | NTUH Hsin-Chu Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Hsin-Chu Branch | Hsinchu | 300 | Taiwan | |||
| National Taiwan University Hospital, Hsin-Chu Branch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25239073 | Result | Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17. | |
| 19583663 | Result | Haugen AS, Eide GE, Olsen MV, Haukeland B, Remme AR, Wahl AK. Anxiety in the operating theatre: a study of frequency and environmental impact in patients having local, plexus or regional anaesthesia. J Clin Nurs. 2009 Aug;18(16):2301-10. doi: 10.1111/j.1365-2702.2009.02792.x. |
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available upon reasonable request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2026 | May 11, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2024 | May 10, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 3 minutes |
| Hsinchu |
| Taiwan |
| 25641687 | Result | Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30. |
| 37199436 | Result | Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17. |
| 10875713 | Result | Klopfenstein CE, Forster A, Van Gessel E. Anesthetic assessment in an outpatient consultation clinic reduces preoperative anxiety. Can J Anaesth. 2000 Jun;47(6):511-5. doi: 10.1007/BF03018941. |
| 12707146 | Result | Lee A, Chui PT, Gin T. Educating patients about anesthesia: a systematic review of randomized controlled trials of media-based interventions. Anesth Analg. 2003 May;96(5):1424-1431. doi: 10.1213/01.ANE.0000055806.93400.93. |
| 25948900 | Result | Maheshwari D, Ismail S. Preoperative anxiety in patients selecting either general or regional anesthesia for elective cesarean section. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):196-200. doi: 10.4103/0970-9185.155148. |
| 15957691 | Result | Myles PS, Urquhart N. The linearity of the visual analogue scale in patients with severe acute pain. Anaesth Intensive Care. 2005 Feb;33(1):54-8. doi: 10.1177/0310057X0503300108. |
| 28186223 | Result | Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466. |
| 12761468 | Result | Salamon E, Kim M, Beaulieu J, Stefano GB. Sound therapy induced relaxation: down regulating stress processes and pathologies. Med Sci Monit. 2003 May;9(5):RA96-RA101. |
| 37328611 | Result | Soltani P, Moaddabi A, Koochek Dezfuli M, Ebrahimikiyasari S, Hosseinnataj A, Rengo S, Tavakoli Tafti K, Spagnuolo G. Evaluating the effect of using anti-stress balls as a distraction technique in reducing pain during inferior alveolar nerve block injection: a randomized clinical trial. Clin Oral Investig. 2023 Aug;27(8):4653-4658. doi: 10.1007/s00784-023-05091-2. Epub 2023 Jun 17. |
| 33776087 | Result | Sriramka B, Mallik D, Singh J, Khetan M. Effect of hand-holding and conversation alone or with midazolam premedication on preoperative anxiety in adult patients-A randomised controlled trial. Indian J Anaesth. 2021 Feb;65(2):128-132. doi: 10.4103/ija.IJA_705_20. Epub 2021 Feb 10. |
| 29624026 | Result | Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5. |